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Clindamycin 150mg Capsules

Document: leaflet MAH BRAND_PLPI 15184-1611 change

Ref: 1611/250116/1/F

Clindamycin 150mg Capsules

(clindamycin hydrochloride)

Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine

*    Keep this leaflet. You may need to read it again.

*    If you have any further questions, ask your doctor or pharmacist.

*    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Your medicine is called Clindamycin 150mg Capsules but will be referred to as Clindamycin throughout this Patient Information Leaflet.

In this leaflet:

^ What Clindamycin is and what it is used for ^ Before you take Clindamycin [a How to take Clindamycin ^ Possible side effects ^ How to store Clindamycin ^ Further information

^ What Clindamycin is and what it is used for?

Clindamycin contains clindamycin hydrochloride which is an antibiotic used in the treatment of serious bacterial infections.

Before you take Clindamycin

Do not take Clindamycin

If you are allergic (hypersensitive) to clindamycin, lincomycin or to any of the other ingredients in this medicine.

Take special care with Dalacin

Tell your doctor if you have any of the following conditions to help him or her decide if Clindamycin is suitable for you:

*    you have diarrhoea or usually get diarrhoea when you take antibiotics or have ever suffered from problems with your stomach or intestines. If you develop severe or prolonged or bloody diarrhoea during or after using Clindamycin tell your doctor immediately since it may be

necessary to interrupt the treatment. This may be a sign of bowel inflammation (pseudomembranous colitis) which can occur following treatment with antibiotics.

*    you suffer from problems with your kidneys or liver.

*    you suffer from asthma, eczema or hayfever.

Clindamycin does not get into the brain and is therefore not suitable for treating serious infections in and around the brain. Your doctor may need to give you another antibiotic if you have these infections.

Taking other medicines

Some medicines can affect the way this medicine works, or the medicine itself can reduce the effectiveness of other medicines taken at the same time. These include:

*    erythromycin (an antibiotic)

*    muscle relaxants used for operations.

*    oral contraceptive pills. You should use extra contraception such as condoms whilst taking Clindamycin and for seven days after taking Clindamycin.

*    warfarin or similar medicines - used to thin the blood. You may be more likely to have a bleed. Your doctor may need to take regular blood tests to check how well your blood can clot.

Please tell your doctor if you are taking or have recently taken any other medicines including medicines obtained without a prescription.

Taking Clindamycin with food and drink

The capsules may be taken either before or after a meal.

Pregnancy

If you are pregnant or think you might be pregnant you should contact your doctor before taking Clindamycin.

Ask your doctor or pharmacist for advice before taking any medicine. Breast-feeding

Tell your doctor if you will be breast-feeding while taking Clindamycin as the active substance in this medicine may be passed into breast milk. Your doctor will decide if Clindamycin is appropriate for you. Although it is not likely that a nursing infant will take in very much of the active substance from the milk it drinks, if your baby gets bloodstained diarrhoea or shows any signs of illness, tell your doctor at once. You should stop breast-feeding if this happens.

Driving and using machines

No effects on the ability to drive or use machines have been seen with Clindamycin.

Important information about some of the ingredients of Clindamycin Capsules

Clindamycin Capsules contains lactose a type of sugar. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3 How to take Clindamycin

Always take Clindamycin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure how to take this medicine.

Clindamycin Capsules should always be swallowed whole and washed down with a full glass of water.

Adults and Elderly Patients

The recommended dose of Clindamycin is between 150 and 450mg (1 to 3 capsules) every 6 hours, depending on the severity of your infection.

Children

The recommended dose in children is between 3 and 6mg per kg every six hours, depending on the severity of the infection. Your doctor will work out the number of capsules that your child should have.

Long term use of Clindamycin

If you have to take Clindamycin for a long time, your doctor may arrange regular liver, kidney and blood tests. Do not miss these check-ups with your doctor.

Long term use can also make you more likely to get other infections that do not respond to Clindamycin treatment.

If you take more Clindamycin Capsules than you should

If you accidentally take too many Clindamycin Capsules contact your doctor at once or go to the nearest hospital casualty department. Always take the labelled medicine package with you, whether there are any Clindamycin Capsules left or not. Do not take any more capsules until your doctor tells you to.

Clindamycin 150mg Capsules

(clindamycin hydrochloride)

Patient Information Leaflet (continued)

If you miss a dose of Clindamycin

If the forgotten dose is just a few hours late, use it straight away. If it is nearly time for your next dose miss out the forgotten one. Do not take a double dose to make up for a missed dose.

If you stop taking Clindamycin

If you stop taking the medicine too soon your infection may come back again or get worse. Do not stop taking Clindamycin unless your doctor tells you to.

If you have any further questions on how to take this product, ask your doctor or pharmacist.

[4 Possible side effects

Like all medicines, Clindamycin can cause side effects, although not everybody gets them.

Tell your doctor immediately if you develop:

*    severe, persistent or bloody diarrhoea (which may be associated with stomach pain or fever). This is an uncommon side effect which may occur during or after completing treatment with antibiotics and can be a sign of serious bowel inflammation.

*    signs of a severe allergic reaction such as sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body).

*    blistering and peeling of large areas of skin, fever, cough, feeling unwell and swelling of the gums, tongue or lips.

*    yellowing of the skin and whites of the eyes (jaundice).

Other possible side effects may include:

*    Effects on your nervous system: impaired sense of taste

*    Effects on your skin: reddening of the skin, skin rash, itching (hives)

*    Effects on your stomach and intestines: throat ulcers, sore throat, feeling sick, being sick, stomach pain and diarrhoea

*    Effects on your blood system: reduced numbers of blood cells which may cause bruising or bleeding or weaken the immune system

*    Effects on your liver: poor liver function

*    Effects on your genital area: inflammation of the vagina.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

[a Further information

What Clindamycin contains:

Each capsule contains 150mg clindamycin as hydrochloride.

The other ingredients are: lactose, corn starch, talc and magnesium stearate.

What Clindamycin looks like and contents of the pack

Clindamycin Capsules are white hard capsule with markings CLIN 150 and Pfizer in black ink on the cap and body.

Each pack contains 24 Capsules.

Manufacturer and Licence Holder

Manufactured by Pfizer PGM, Zone industrielle-29 route des Industries, 37530 Poce-sur-Cisse, France and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire,

B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

|POM PL 15184/1611 Clindamycin 150mg Capsules Revision date: 25/01/16

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

[a How to store Clindamycin

Do not store above 25°C.

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not take this medicine after the expiry date shown on the blister label or carton. If your doctor tells you to stop taking this medicine, take any remaining medicine back to the pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.

If your medicine become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.

These measures will help protect the environment.